NCT04340089

Brief Summary

This study evaluates the effect of squatting on the toilet on gastric transit time and complete examination rate of capsule endoscopy.In the observation group, the patients could go to squatting on the toilet at any time as they want to after taking the capsule.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

April 15, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

April 7, 2020

Last Update Submit

April 13, 2020

Conditions

Intestinal Diseases

Keywords

squatting on the toiletcapsule endoscopy

Outcome Measures

Primary Outcomes (1)

  • CER

    complete examination rate

    72 hours

Secondary Outcomes (1)

  • GTT

    72 hours

Study Arms (2)

observation group

the patients can go to squatting on the toilet at any time as they want to after taking the capsule

Behavioral: squatting on the toilet

control group

The patients can move freely

Interventions

squatting on the toiletBEHAVIORAL

the patients could go to squatting on the toilet at any time as they want to after taking the capsule

observation group

Eligibility Criteria

Age8 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the patients needed to the examination of capsule endoscopy.

You may qualify if:

  • unexplained gastrointestinal bleeding, unexplained chronic abdominal pain and diarrhea, suspected Crohn's disease, suspected small intestinal tumor, and patients needing to exclude small intestinal diseases.

You may not qualify if:

  • suspected intestinal obstruction and intestinal stenosis, esophageal stenosis or dysphagia, history of abdominal operation, or diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Song He, Dr.

    Director of department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 9, 2020

Study Start

April 15, 2020

Primary Completion

September 30, 2021

Study Completion

March 31, 2022

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations

CN(1)